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- Tasks: Manage clinical supply strategies and collaborate with global teams to ensure optimal study support.
- Company: Leading pharmaceutical company focused on innovative drug development.
- Benefits: Competitive hourly rate, remote work flexibility, and professional growth opportunities.
- Why this job: Be at the forefront of clinical trials and make a real difference in healthcare.
- Qualifications: Experience in pharma and clinical supplies, strong project management skills required.
- Other info: Dynamic role with opportunities for conflict resolution and team leadership.
Trial Supplies Management Manager
Location: Remote role – Uxbridge 1-2 times per month
Pay rate: £28.76 per hour
Duration: 6 months
Hours 35 hours per week
Position Summary:
Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision.
Roles and Responsibilities
• Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met.
• Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals. Demonstrates strong knowledge of GCSC processes when presenting at cross-functional meetings.
• Responsible for identifying and supporting strategies for continuous improvement, both departmental and/or inter-departmental.
• Influences clinical and development timelines, study design and country selection. Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams.
• Develops supply forecasts for studies through evaluation of the clinical development plan and protocol analysis. Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
• Issues Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing & Controls (CMC) team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements.
• Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo, and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites.
• Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements.
• Participates in development, review and approval of Interactive Response Technology (IRT) specifications. Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements.
• Actively participates in internal meetings any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.
• Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements. Attends meetings with vendors and generates purchase requisitions as needed. Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans.
• Acts as the main Clinical Supplies contact person for the assigned compound and associated studies, leading communications regarding global supply strategy with study team as appropriate.
• Supports associated actions stemming from change controls.
• In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
• Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution.
• Manages conflicts/issues with internal and external partners and customers.
Skills and Qualifications:
• Minimum Pharma industry related experience.
• Minimum Clinical Supplies/Development with global experience or equivalent experience.
• Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
• Proficient and strong Project management skills.
• Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc.
• Proficient knowledge of import / export requirements.
• Proficient/Strong knowledge of IVRS and CTMS systems.
• Proficient / Strong knowledge of industry technology.
• Applies and drives Forecasting and Planning activity as it relates to protocol.
• Ability to build/drive internal team consensus.
• Conflict resolution
• Negotiation
• Coaching and mentoring
Trial Supplies Management Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Trial Supplies Management Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma industry and let them know you're on the hunt for a Trial Supplies Management Manager role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of global drug development processes and regulatory requirements. We want you to shine when discussing how you can influence clinical timelines and study designs!
✨Tip Number 3
Showcase your project management skills during interviews. Be ready to share examples of how you've successfully managed supply strategies or resolved conflicts with internal and external partners. This will demonstrate your ability to lead communications effectively.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Trial Supplies Management Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Trial Supplies Management Manager role. Highlight relevant experience in clinical supply chain management and any specific projects that align with the job description. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. Don’t forget to mention your understanding of global drug development processes, as that’s key for us.
Showcase Your Project Management Skills: Since project management is crucial for this position, be sure to highlight your experience in managing timelines and coordinating with various teams. We love seeing examples of how you've successfully navigated complex projects in the past!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It helps us keep track of applications and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Stuff
Make sure you brush up on your knowledge of the global drug development process and regulatory requirements. Familiarise yourself with the specific responsibilities of a Trial Supplies Management Manager, as this will help you answer questions confidently and demonstrate your expertise.
✨Showcase Your Collaboration Skills
Since this role involves working closely with various teams and external partners, be prepared to discuss examples of how you've successfully collaborated in the past. Highlight any experiences where you influenced timelines or contributed to cross-functional projects.
✨Prepare for Scenario Questions
Expect to face scenario-based questions that assess your problem-solving skills and ability to manage conflicts. Think of specific situations where you had to resolve issues or improve processes, and be ready to explain your thought process and the outcomes.
✨Demonstrate Your Project Management Prowess
As project management is key in this role, come equipped with examples of how you've managed projects in the past. Discuss your approach to forecasting, planning, and ensuring timely delivery of supplies, as well as any tools or methodologies you used.
